Efficacy and Toxicity of Increasing Doses of Idarubicin, Cytarabine and G-CSF in Acute Myeloid Leukemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
Sponsor:
Collaborators:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Ministry of Health, Spain
Information provided by (Responsible Party):
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
ClinicalTrials.gov Identifier:
NCT01700413
First received: October 1, 2012
Last updated: February 12, 2013
Last verified: February 2013

October 1, 2012
February 12, 2013
October 2012
October 2013   (final data collection date for primary outcome measure)
Rate of complete remissions (CR) [ Time Frame: From 28 up to 56 days after first induction ] [ Designated as safety issue: No ]
Identify the highest dose of idarubicin in combination with cytarabine and G-CSF that produces a CR rate equal to or greater than 65% with tolerable toxicity.
Same as current
Complete list of historical versions of study NCT01700413 on ClinicalTrials.gov Archive Site
  • Rate of patients with adverse events as a measure of safety and tolerability [ Time Frame: Weekly during treatment, and on months 3 and 6 after complete response ] [ Designated as safety issue: Yes ]
    Hematologic toxicity Gastrointestinal and liver toxicity Cardiac Toxicity Fever and infection Pulmonary complications Duration of hospitalization Mortality and causes of death induction.
  • Duration of hospitalization [ Time Frame: From the inclusion until 9 months after inclusion. ] [ Designated as safety issue: No ]
    Number of days in which the patient is hospitalized.
  • Mortality (as rate) related to study treatment [ Time Frame: Weekly during treatment, 3 months after complete remission, 6 months after complete remission and 9 months after complete remission ] [ Designated as safety issue: Yes ]
    Causes of death, mortality related treatment, mortality in induction.
  • Relapse at 6 months [ Time Frame: 6 months from complete remission, expected to be within 9 months from inclusion. ] [ Designated as safety issue: No ]
    Rate of patients that have relapsed within 6 months after complete remission.
  • Survival at 9 months from diagnosis [ Time Frame: 9 months after diagnoses ] [ Designated as safety issue: No ]
    Rate of patients alive at 9 months after diagnosis.
Same as current
Not Provided
Not Provided
 
Efficacy and Toxicity of Increasing Doses of Idarubicin, Cytarabine and G-CSF in Acute Myeloid Leukemia
Treatment of di Novo Acute Myeloid Leukemia With the Combination of Increasing Doses of Idarubicin, Cytarabine and Sensitization (Priming) With G-CSF. A Phase II Prospective Study of Toxicity and Efficacy.

While several studies have been reported with increasing doses of daunorubicin in the first line treatment of Acute Myeloid Leukemia (AML), there is no similar experience with idarubicin as initial treatment of AML.

As idarubicin is the most common treatment used for AML, it is needed to find the optimal dose for the combination of idarubicin, cytarabine and G_CSF, to explore if this combination improves the outcomes of current treatments for AML.

The aim of this dose-finding study is to find the optimal dose for the combination of idarubicin, cytarabine and G-CSF that could improve the response rate, reduce relapse and improve survival of patients with primary acute myeloid leukemia. This could be a significant advance in a field where treatment outcomes have stabilized in the last 15 years. This study will be the basis for further prospective, randomized, multicenter trial comparing idarubicin maximum tolerated dose, compared to standard treatment with idarubicin and cytarabine, including raising both arms in G-CSF. The dose of 12 mg/m2 will be administered as control arm in this future randomized study, which will investigate the benefit of enhanced dose identified as optimal in this phase II pilot study.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Di Novo Acute Myeloid Leukemia
Drug: Idarubicin
Experimental: Idarubicin
Cohort 1: Idarubicin 14 mg/m2 (day 1-3), Cytarabine 200 mg/m2 (Days 1-7), G-CSF 150 mcg/m2/day Cohort 2: Idarubicin 16 mg/m2 (day 1-3), Cytarabine 200 mg/m2 (Days 1-7), G-CSF 150 mcg/m2/day Cohort 3: Idarubicin 18 mg/m2 (day 1-3), Cytarabine 200 mg/m2 (Days 1-7), G-CSF 150 mcg/m2/day
Intervention: Drug: Idarubicin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
December 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

Informed consent signature Patients with newly diagnosed AML, classified according to WHO criteria. Age more than or equal to 18 and less than or equal to 70 years.

Exclusion Criteria:

Patients previously treated with chemotherapy for their AML other than hydroxyurea.

Acute promyelocytic leukemia with t (15; 17). Blast crisis of chronic myeloid leukemia. Leukemias that appear after other myeloproliferative neoplasms. Leukemias ensuing myelodysplastic syndromes after more than 6 months. Presence of other malignancies in activity. AML secondary to chemo-radiotherapy treatment for other malignancies. Abnormal renal and hepatic function, with creatinine value and / or bilirubin 2 times the normal limit value, except where the alterations are attributable to leukemia.

Patients with markedly reduced ejection fraction (less than 45%), symptomatic heart failure, or both of the normal value of the center.

Patients with serious concomitant psychiatric or neurological disease. HIV-positive. Pregnancy or breastfeeding

Both
18 Years to 70 Years
No
Contact: Salut Brunet, MD + 34 93 434 44 12 investigacion@mfar.net
Contact: Federico Nepote, PhD + 34 93 434 44 12 federico.nepote@mfar.net
Spain
 
NCT01700413
IIBSP-CSF-2011-141
No
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  • Ministry of Health, Spain
Study Chair: Salut Brunet, MD Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP